Overview:Sterilizing filtration, utilizing membrane filter often of 0.2 micron rating, are critical in aseptic processing. As soon as heat sterilization cannot be used or bioburden requires to be reduced before heat sterilization, sterilizing grade filters are installed to remove the microbial burden.

Since an increasing fluid area cannot be heat sterilized, aseptic processing and the use of sterilizing grade filters are gaining importance. Filter manufacturers are able to supply filter qualification data, but these results are established under specific lab conditions and appropriate process validation requires to be performed by the end-user of the filter. Process validation takes the fluid to be filtered into consideration and the process parameters, used during filtration. Process validation is not only a regulatory requirement, but creates assurance that the filter used is of right choice and performs as expected. Regulatory guidance documents, like the FDA Aseptic Processing Guidance of 2004 and EC cGMP Annex 1 describe filter validation requirements, the most thorough though being PDA’s Technical Report #26, 2008. The webinar will describe filter qualification activities performed by the filter manufacturer and the resulting data. It will also touch on the guidances mentioned and the requirements set within. Followed by a detailed, step by step description of process validation needs and why these steps are of importance.

Why should you attend:

Participants will learn what are essential requirements of sterilizing filter process validation.

Participants will learn the details of individual process validation activities

Participants will learn how to differentiate between the absolute essential and useful process validation steps.

Participants will also the difference between qualification and process validation.

Multiple guidance documents will be discussed in regard to sterilizing grade filtration

In essence You will learn how important process validation of sterilizing filters is and what steps are required to perform such validation.

Areas Covered in the Session:

Introduction

Filter Qualification

Guidances

Process Validation:

Viability test

Bacteria Challenge test

Chemical compatibility

Adsorption analysis

Extractables analysis

Particulates

Product-wet integrity testing

Other evaluations

Conclusion

Questions & Answers

Who Will Benefit:

Validation management

Quality Unit Vice Presidents, Directors and Managers

Vice presidents, Directors and Managers of pharmaceutical operations

Process development Management and Technicians

Regulatory and Compliance Management

Consultants

Maik Jornitz is Chief Operating Officer at G-CON Manufacturing LLC, College Station, TX. ?With over 25 years of experience in separation and single-use technologies, the related regulations and validation requirements, Jornitz supports the biopharmaceutical industry on a world-wide basis.